Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis: 2-year results of a randomised trial Journal Articles uri icon

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  • ObjectivesThe RITUXVAS trial reported similar remission induction rates and safety between rituximab and cyclophosphamide based regimens for antineutrophil cytoplasm antibody (ANCA)-associated vasculitis at 12 months; however, immunosuppression maintenance requirements and longer-term outcomes after rituximab in ANCA-associated renal vasculitis are unknown.MethodsForty-four patients with newly diagnosed ANCA-associated vasculitis and renal involvement were randomised, 3:1, to glucocorticoids plus either rituximab (375 mg/m2/week×4) with two intravenous cyclophosphamide pulses (n=33, rituximab group), or intravenous cyclophosphamide for 3–6 months followed by azathioprine (n=11, control group).ResultsThe primary end point at 24 months was a composite of death, end-stage renal disease and relapse, which occurred in 14/33 in the rituximab group (42%) and 4/11 in the control group (36%) (p=1.00). After remission induction treatment all patients in the rituximab group achieved complete B cell depletion and during subsequent follow-up, 23/33 (70%) had B cell return. Relapses occurred in seven in the rituximab group (21%) and two in the control group (18%) (p=1.00). All relapses in the rituximab group occurred after B cell return.ConclusionsAt 24 months, rates of the composite outcome of death, end-stage renal disease and relapse did not differ between groups. In the rituximab group, B cell return was associated with relapse.Trial registration numberISRCTN28528813.


  • Jones, Rachel B
  • Furuta, Shunsuke
  • Cohen Tervaert, Jan Willem
  • Hauser, Thomas
  • Luqmani, Raashid
  • Morgan, Matthew D
  • Peh, Chen Au
  • Savage, Caroline O
  • Segelmark, Marten
  • Tesar, Vladimir
  • van Paassen, Pieter
  • Walsh, Michael
  • Westman, Kerstin
  • Jayne, David RW

publication date

  • June 2015

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